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Recall Observatory FDA recall evidence

Device product

Latex Dental Dams labeled as Non-Latex Dental Dams

Z-2151-2014

December 11, 2013

Class II

Product summary

Firm
Coltene Whaledent Inc
Event
Event 67640
Status
Terminated
Classification
Class II
Quantity
32 boxes, 15 individual dams per box
Official record key
device-enforcement:Z-2151-2014

Official wording

Reason: Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

Code information: Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10

Distribution pattern: Distributed in Memphis, TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.